Albuterol Integrated Adherence Monitoring in Children With Asthma

Not Applicable

Completed

• Conditions: Asthma in Children
• Interventions: Device: Digihaler Albuterol Device by TEVA

• Registration Number: NCT04896645
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

The investigators propose to evaluate whether an integrated electronic adherence monitoring albuterol rescue inhaler can improve proper use in a mostly minority and inner-city population of children treated for asthma at the Children's Hospital of Los Angeles

Detailed Description

This study is designed to (1) determine whether an integrated EAM albuterol rescue inhaler can increase proper use (2) determine if the monitoring capabilities of the device (flow rate, warnings) and/or increased proper use from having the device correlate with better outcomes. The investigators will also have patients perform at-home gamified spirometry (Aluna ©) to (3) determine if at-home spirometry can predict albuterol use or change outcomes.

Study Timeline

• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-21
• Study Start: 2021-06-01
• Primary Completion: 2022-06-22
• Study Completion: 2022-06-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Patients 8 to <19 years of age with a diagnosis of asthma as ICD-9 code 493 or ICD-10 code J45 seen in the allergy clinic at CHLA who have an albuterol rescue inhaler already prescribed and access to a personal smartphone will be eligible for recruitment.

Exclusion Criteria

• Patients unable to use device, unable to use albuterol (i.e. must use levalbuterol) or Age < 4 (ProAir® Digihaler only approved for Subjects 4 years and older). Patients with other chronic lung disease besides asthma or other significant comorbidities that could affect lung function/asthma (e.g. significant heart defects, immunodeficiency, cystic fibrosis, etc).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients 8 to <19 years of age with a diagnosis of asthma	Digihaler Albuterol Device by TEVA	Patients 8 to \<19 years of age with a diagnosis of asthma as ICD-9 code 493 or ICD-10 code J45 seen in the allergy clinic at CHLA who have an albuterol rescue inhaler already prescribed and access to a personal smartphone will be eligible for recruitment.

Primary Outcome Measures

Name	Time	Method
Asthma Adherence	3 months	Test of Adherence to Inhalers (TAI)
Asthma Outcomes	3 months	Asthma Control Test (ACT)
Albuterol Use	3 months	Questionnaires created by investigators addressing when and how often albuterol is used for symptoms, illness, etc.

Secondary Outcome Measures

Name	Time	Method
Spirometry	3 months	Aluna at home gamified spirometer, measures full spirometry FEV1, FVC, FEV1/FVC, Peak Flow.
Asthma Quality of Life	3 months	PedsQL (Pediatric Quality of Life Inventory)
Lung Function	3 months	Microlife FEV1, measures FEV1

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States